Pedicle screw having a removable rod coupling

ABSTRACT

The present invention provides a pedicle screw for spinal fixation having a bone fastener portion a permanent rod coupling, a breakaway portion connected to the permanent rod coupling and a temporary rod coupling. A permanent rod can be positioned in the permanent rod coupling and a temporary rod can be positioned in the temporary rod coupling and when the temporary rod is not needed the temporary rod coupling can be removed by separation at a breakaway portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation-In-Part of U.S. patent applicationSer. No. 13/410,035 filed Mar. 1, 2012 and claims priority to U.S.patent application Ser. No. 12/364,412 filed Feb. 2, 2009 and claimspriority to U.S. Provisional Application Ser. No. 61/025,761, filed Feb.2, 2008, and to U.S. Provisional Application Ser. No. 61/080,162 filedJul. 11, 2008, the contents of each which are incorporated herein byreference.

TECHNICAL FIELD OF THE INVENTION

The present invention relates in general to the field of bone fixation,and more particularly, to a novel pedicle screw having a removable rodcoupling for use during the surgical correction of mild to severe rigidspinal deformities.

STATEMENT OF FEDERALLY FUNDED RESEARCH

None.

BACKGROUND OF THE INVENTION

Without limiting the scope of the invention, its background is describedin connection with pedicle screws. In rigid severe spine deformity withcoronal or sagittal decompensation, translation of the spinal column isnecessary for restoration of trunk balance as well as deformitycorrection. However, the conventional correction methods, such asposterior correction only or anterior release and posteriorinstrumentation, are usually unsatisfactory. Therefore, a moreaggressive approach, such as reconstructive techniques, is necessary. In1922, Maclennan¹ first illustrated vertebrectomy and demonstrated anapical resection from a posterior-only approach with postoperativecasting for the treatment of severe scoliosis. Several authors²⁻⁸ havesubsequently reported their experience with vertebrectomy, mostly forcongenital scoliosis. In 1987, Bradford⁹ performed both anterior andposterior vertebral column resection (VCR) with spinal shortening andposterior instrumentation and fusion demonstrating excellent restorationof coronal with relatively few complications. Leatherman⁶ introduced atwo-stage anterior and posterior correction procedure for congenitalspinal deformity. Bradford and Bochie-Adjei¹⁰ also reported a singlestage anterior and posterior resection of hemivertebra and spinalarthordesis. However, the anterior-posterior vertebral column resection(VCR) has disadvantages such as long operative time, potentialsignificant blood loss, and risk of intraoperative neurologic impairmentdue to the spinal column segment instability during the resection andthe correction procedure.

In 2002, Suk¹¹⁻¹³ introduced a technique of a single posterior approachto perform VCR (PVCR) that offered significant advantages over thecombined anterior-posterior VCR. The surgery consisted of temporarystabilization of the vertebral column with segmental pedicle screwfixation, resection of the vertebral column at the apex of the deformityvia the posterior route, followed by gradual deformity correction andglobal fusion. In the surgical technique, multiple pedicle screws wereutilized proximal and distal to the vertebral resection to securely fixthe spine prior to any bony resection. Provisional single rod placementis performed during the bony resection to prevent sudden spinal columntranslations which may result in spinal cord injury. The vertebralcolumn resection and deformity correction were carried out either byexchanging the temporary precontoured rods one by one or by in situ rodbending. However, these techniques have a number of disadvantages: 1)the risk of intraoperative mishaps due to the instability resulting fromexchanging the temporary rods may produce spinal cord injury; 2)limitation in deformity correction secondary to a “one-time” correctionmaneuver utilized using the Suk technique; 3) short segment fixationusing the provisional rods since multiple exchanges prevent long rodutilization; and 4) additional surgical time necessary with multipleremoval and insertion of the temporary provisional rods.

One such fixation system is taught in U.S. Pat. No. 7,220,262, issued toHynes. Briefly, the spinal fixation system and related methods includepedicle screws secured in two columns, one along each side of the spine.Cross support rods have ends connected to pedicle screw heads. Alongitudinally extending rod is supported on the cross supports andrecessed in the cavity created by removal of portions of spinousprocesses, providing a reduced profile of the installed construct.Several types of cross supports are shown, such as: arms from the screwsinward to rings or yokes connecting the longitudinal rod; cross rodswith ends connected to the screws and having centrally-located yokes forthe longitudinal rod; cross rods with articulating longitudinal rodportions fixed or swiveled to them. These cross rods may have endportions angled posterior toward anterior to accommodate lateralpositioned pedicle screws, but shorter cross rods without angled endportions enable medialized pedicle screw orientation.

U.S. Publication No. US20070270810, filed by Sanders is directed to apedicle screw spinal rod connector arrangement. Briefly, a pedicle screwspinal rod connector arrangement is provided that includes in a bodyhaving an opening for mounting a head of an inserted pedicle screw. Abracket connected with the body forms a lateral restraint. A bridge isconnected with and extends over the body. A spinal rod-receiving slot isprovided between the bridge and the bracket. The connector arrangementalso has a wedge axially offset from the pedicle screw moveable downwardby a setscrew mounted with the bridge. The wedge imparts a locking forceon the pedicle screw head and a generally lateral locking force on thespinal rod.

Yet another example is shown in U.S. Publication No. US20070233062,filed by Berry for a pedicle screw system with offset stabilizer rod. Inthis example, an improved pedicle screw system is provided with anoffset stabilizer rod for the internal fixation of the spine. Thepedicle screw system includes at least two multi-angle pedicle screwunits adapted for anchored securement to patient bone, and an elongatedstabilizer rod extending there between. Each pedicle screw unit includesa bone screw associated with an anchor bracket defining a laterallyoffset and upwardly open channel or trough for receiving and supportingthe stabilizer rod. A securement member such as a set screw is fastenedto the anchor bracket for compressively retaining the stabilizer rodwithin the bracket channel or trough. The securement member may alsobear against the associated bone screw for compressively retaining thescrew in position relative to the anchor bracket.

SUMMARY OF THE INVENTION

The present invention solves various problems of current spinal fixationsystems and the control of the positioning of temporary rods duringspinal surgery. The present invention allows the surgeon to stabilizethe spine, effectively derotate the spine, safely translate the spine,and when required, easily derotate and translate the spine to treatspinal deformities.

The present invention provides a pedicle screw for spinal fixationcomprising: a bone fastener portion, wherein the bone fastener portionis at least partially threaded; a permanent rod coupling comprising abottom surface connected to the bone fastener portion, a middle sectionpositioned between the bottom surface and a top surface, a lateral rodopening in a portion of the middle section adapted to receive apermanent rod, a threaded bore that extends from the top surface intothe lateral rod opening, a permanent rod fastener mated to fit thethreaded bore to extend into the lateral rod opening, wherein thepermanent rod fastener can engage a permanent rod positioned in thelateral rod opening, and a transition region on a portion of the topsurface; a breakaway portion in the transition region; a temporary rodcoupling connected to the transition region, wherein the temporary rodcoupling comprises a temporary rod channel adapted to receive atemporary rod, an upper threaded opening that extends into the temporaryrod channel, and an upper rod fastener mated to the upper threadedopening, wherein the upper rod fastener can engage the temporary rodpositioned in the temporary rod channel; wherein the permanent rod ispositioned in the lateral rod opening and secured by the permanent rodfastener during the bone alignment and the temporary rod is temporarilypositioned in the temporary rod channel and secured by the upper rodfastener during a bone realignment and when the temporary rod is notneeded the temporary rod coupling can be removed at the transitionregion by separation at the breakaway portion to leave the top surface.

The permanent rod fastener, the upper rod fastener or both are threaded.The lateral rod opening and the temporary rod channel may be generallyperpendicular. The temporary rod channel and the bone fastener portionmay be generally parallel. The lateral rod opening and the bone fastenerportion may be generally perpendicular. The permanent rod fastener, theupper rod fastener or both may further include a locking pin to preventmovement. The bone fastener may be permanently attached to the permanentrod coupling. The bone fastener may be semi-permanently attached to thepermanent rod coupling to allow the permanent rod coupling to bepositioned at a variable angle relative to the bone fastener.

The present invention provides a method of spinal fixation using pediclescrews by fastening two or more pedicle screws into two or morevertebra, wherein the each of the two or more pedicle screws comprise abone fastener portion; a permanent rod coupling comprising a bottomsurface connected to the bone fastener portion, a middle sectionpositioned between the bottom surface and a top surface, a lateral rodopening in a portion of the middle section adapted to receive apermanent rod, a threaded bore that extends from the top surface intothe lateral rod opening, a permanent rod fastener mated to fit thethreaded bore to extend into the lateral rod opening, wherein thepermanent rod fastener can engage a permanent rod positioned in thelateral rod opening, and a transition region on a portion of the topsurface; a breakaway portion in the transition region; a temporary rodcoupling connected to the transition region, wherein the temporary rodcoupling comprises a temporary rod channel adapted to receive atemporary rod, an upper threaded opening that extends into the temporaryrod channel, and an upper rod fastener mated to the upper threadedopening, wherein the upper rod fastener can engage the temporary rodpositioned in the temporary rod channel; and interconnecting the two ormore pedicle screws by securing the permanent rod in the lateral rodopening of at least two of the two or more pedicle screws, securing thetemporary rod in the temporary rod channel of at least two of the two ormore pedicle screws, or both. The method may further include the step ofremoving the temporary rod from the temporary rod channel. The mayfurther include the step of breaking the temporary rod coupling at thebreakaway portion of the transition region to leave the top surface.

The present invention provides a pedicle screw kit for spinal fixationcomprising two or more pedicle screws, wherein each of the two or morepedicle screws comprise a bone fastener portion, wherein the bonefastener portion is at least partially threaded; a permanent rodcoupling comprising a bottom surface connected to the bone fastenerportion, a middle section positioned between the bottom surface and atop surface, a lateral rod opening in a portion of the middle sectionadapted to receive a permanent rod, a threaded bore that extends fromthe top surface into the lateral rod opening, a permanent rod fastenermated to fit the threaded bore to extend into the lateral rod opening,wherein the permanent rod fastener can engage a permanent rod positionedin the lateral rod opening, and a transition region on a portion of thetop surface; a breakaway portion in the transition region; a temporaryrod coupling connected to the transition region, wherein the temporaryrod coupling comprises a temporary rod channel adapted to receive atemporary rod, an upper threaded opening that extends into the temporaryrod channel, and an upper rod fastener mated to the upper threadedopening, wherein the upper rod fastener can engage the temporary rodpositioned in the temporary rod channel; wherein the permanent rod ispositioned in the lateral rod opening and secured by the permanent rodfastener during the bone alignment and the temporary rod is temporarilypositioned in the temporary rod channel and secured by the upper rodfastener during a bone realignment and when the temporary rod is notneeded the temporary rod coupling can be removed at the transitionregion by separation at the breakaway portion to leave the top surface.The kit may further include a breakaway tool adapted to fit thetemporary rod coupling to break off the temporary rod coupling. The kitmay further include one or more rod link reducers, at least onepermanent rod, at least one temporary rod, one or more leverage handlesor a combination thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the features and advantages of thepresent invention, reference is now made to the detailed description ofthe invention along with the accompanying FIGURES and in which:

FIG. 1 shows one embodiment of the pedicle screw of the presentinvention.

FIGS. 2A to 2C show a cross-sectional view of the pedicle screw inoperation.

FIGS. 3A and 3B show an isometric view and a cross-sectional view,respectively, of the pedicle screw.

FIGS. 4A and 4B show an isometric view and a cross-sectional view,respectively, of the pedicle screw.

FIGS. 5A and 5B show an isometric view and a cross-sectional view,respectively, of the pedicle screw.

FIGS. 6A and 6B show an isometric view and a cross-sectional view,respectively, of the pedicle screw.

FIGS. 7A and 7B show an isometric view and a cross-sectional view,respectively, of the pedicle screw.

FIG. 8 shows a rod link reducer 100 for use with the present invention.

FIG. 9 is a cross-sectional side view of one embodiment of the rod linkreducer 100 of the present invention.

FIG. 10 is a side view of one embodiment of a rod manipulator.

FIGS. 11 to 13 show the first step in a spinal fixation process.

FIG. 14 shows the use of the rod link reducer and pedicle screw of thepresent invention.

FIG. 15 shows an overlay of the planning and tools for a surgicalprocedure to correct a severe spinal deformity.

FIGS. 16A to 16E shows a procedure that includes distraction,translation and apical derotation for correction of a single severespinal curve.

FIGS. 17A to 17E shows a procedure for correction of a double majorsevere spinal curve (Thoracic and Lumbar curve).

FIG. 18 is a detailed view of one embodiment of an apical derotationwithout linking the two pedicle screws.

FIG. 19 is an isometric view of a design of the rod-link reducer of thepresent invention.

FIG. 20 is an isometric view of another design of the rod-link reducerof the present invention.

FIG. 21 is an isometric view of another design of the rod-link reducerof the present invention.

FIGS. 22A to 22C shows a six-segment plastic spine model which wasinstrumented to test three constructs: (A) temporary rod/apical rod-linkreducer (left panel); (B) provisional rod (center panel); and (C) finalrod (right panel).

FIG. 23 is a picture that illustrates a perspective view of a rod-linkreducer which links and locks the provisional rods on the concavity.

FIG. 24 is a picture that illustrates a perspective view of a rod-linkreducer which links and locks the provisional rods on the convexity.

FIGS. 25-26 are pictures illustrating a perspective view of the parts ofthe rod-link reducer.

FIG. 27 is a picture that illustrates a cross sectional view of therod-link reducer on the coronal plane.

FIG. 28 is a picture that illustrates a cross sectional view of therod-link reducer on the sagittal plane.

FIG. 29 is an image that shows the pedicle screws, provisional rods, andtwo rod-link-reducers which are fixed in a coronal curve deformitymodel.

FIG. 30 is an image that shows the rod-link-reducers correcting thecoronal curve.

FIG. 31 is an image that shows the provisional rods, therod-link-reducers, and the final rods with a spine that has beencorrected.

FIG. 32 is an image that shows the final rods with a spine that has beencorrected.

FIG. 33 is an image that shows the rod-link-reducers to correct thesagittal curve to the normal kyphosis.

FIG. 34 is an image that shows the rod-link-reducers to correct thesagittal curve to the normal lordosis.

FIG. 35 is an image that shows the pedicle screws, provisional rods, andtwo rod-link-reducers fixed in a sagittal curve deformity model.

FIG. 36 is an image that shows the final rod insertion after thesagittal curve correction.

FIG. 37 is an image that shows the final rods with a spine that has beencorrected.

FIGS. 38A and 38B are images of different embodiments of the presentinvention that show the rigid mechanical connection between theprovisional rods and the links.

FIG. 39 is a top view of one embodiment of the present invention thatshows the rigid mechanical connection between the provisional rods andthe links.

FIG. 40 is a bottom side view of one embodiment of the rod manipulator.

FIG. 41 is a side view of a wide stance embodiment of the presentinvention that shows the rigid mechanical connection between theprovisional rods and the links.

FIG. 42 is a bottom side view of one embodiment of the rod manipulator.

FIG. 43 is a side view of one embodiment of a rod clamp of the presentinvention.

FIG. 44 is a side view of one embodiment of a rod clamp 500 of thepresent invention.

FIG. 45 is a side view of one embodiment of a rod clamp of the presentinvention in operation.

FIG. 46 is a side view of some of the rods used with the presentinvention.

FIG. 47 is a side view of one embodiment of the rod manipulator havingan adjustable joint in the handle ending in a “T” handle.

FIGS. 48A and 48B are images of the joint adapted into a larger device.

FIG. 49 is an exploded isometric image of the joint adapted into alarger device.

FIG. 50 is a view of one embodiment of a rod clamp of the presentinvention in operation.

FIG. 51 is a view of another embodiment of a rod clamp of the presentinvention in operation.

FIG. 52 shows an isometric view of one embodiment of the pedicle screwhaving a removable upper rod coupling.

FIG. 53 shows a side view of one embodiment of the pedicle screw havinga removable upper rod coupling.

FIG. 54 shows a front view of one embodiment of the pedicle screw havinga removable upper rod coupling.

FIG. 55 shows an isometric view of one embodiment of the pedicle screwhaving a removable upper rod coupling showing the permanent rod andtemporary rod.

FIG. 56 shows an isometric view of one embodiment of the pedicle screwhaving a removable upper rod coupling showing temporary rod with theupper rod coupling removal tool.

FIG. 57 shows an isometric view of one embodiment of the pedicle screwhaving a removable upper rod coupling showing temporary rod with theupper rod coupling removal tool.

FIG. 58 shows an isometric view of one embodiment of the pedicle screwshowing the permanent rod with the upper rod coupling removed.

FIG. 59 shows an isometric view of one embodiment of the pedicle screwwith the upper rod coupling removed.

DETAILED DESCRIPTION OF THE INVENTION

While the making and using of various embodiments of the presentinvention are discussed in detail below, it should be appreciated thatthe present invention provides many applicable inventive concepts thatcan be embodied in a wide variety of specific contexts. The specificembodiments discussed herein are merely illustrative of specific ways tomake and use the invention and do not delimit the scope of theinvention.

To facilitate the understanding of this invention, a number of terms aredefined below. Terms defined herein have meanings as commonly understoodby a person of ordinary skill in the areas relevant to the presentinvention. Terms such as “a”, “an” and “the” are not intended to referto only a singular entity, but include the general class of which aspecific example may be used for illustration. The terminology herein isused to describe specific embodiments of the invention, but their usagedoes not delimit the invention, except as outlined in the claims.

Posterior vertebral column resection (PVCR) can be used for correctionof the most severe spinal deformities. Current implant strategies usedfor more common and moderate spinal deformity are not ideal for thosecomplex cases. Therefore, they do not provide continuous stability ofthe spine as one transition between resection and correction, arecumbersome, and the application of correction forces are not ideal. Thenew system disclosed herein was designed specifically to surgicallytreat severe spinal deformity.

The treatment of severe rigid spinal deformity is a demanding anddifficult surgical challenge. The PVCR has been considered to be aneffective alternative to the conventional anteriorposterior VCR insevere rigid spinal deformity. However, the current implant strategiesused during PVCR allow for limited correction, potential risk of spinalcord injuries, and long operative time. This new instrumentation systemof the present invention offers: 1) better maintenance of spinalstability throughout the surgical procedure to reduce risk of the spinalcord injuries; 2) more reliable reconstruction of the vertebral column;3) better and easier correction of the deformity; and 4) shorteroperative time.

The novel pedicle screw/rod-link reducer posterior instrumentationsystem was developed to provide a safer, easier and improved deformitycorrection, as well as shorter surgical time for the PVCR of the severespinal deformity. Biomechanical evaluation of this system demonstratedspinal stability throughout the surgical procedure to reduce the risk ofspinal cord injuries.

The temporary rod/rod-link reducer construct provided similar stiffnessand stability compared to the provisional and final rod constructs. Thisnew system offers a safer, easier and improved deformity correction, aswell as shorter surgical time for the PVCR of the severe spinaldeformity.

Significance: Current implant strategies used for more common andmoderate spinal deformity are not ideal for the most severe spinaldeformities. A novel pedicle screw/rod-link reducer has been designed tooffer better maintenance of spinal stability throughout the surgicalprocedure to reduce risk of the spinal cord injuries. This systemtherefore provides a safer, easier and improved deformity correction, aswell as shorter surgical time for the PVCR of the severe spinaldeformity.

Implant Components: The instrumentation system of the present inventionincludes one or more of the following components: a pedicle screw, arod-link reducer, reduction handle, temporary long rod, and final rod.The pedicle screw includes a threaded shank for insertion into the boneand a screw head having a first aperture and a second aperture. Thefirst aperture has a basic “U” (tulip) shape (top-loading component)that extends from the top of the screw head and is open on both sides ofthe screw head to receive a first longitudinal member (a temporary rod)and a set of female threads formed in the inner walls of the firstaperture. A first compression member engages the set of female threadsof the first aperture and the face of the first compression membercontacts the first longitudinal member. The second aperture has a basic“C” shape (side-loading component) that lines up superior to thethreaded shank and inferior to the first aperture. The second apertureis open on both sides of the head to receive a second longitudinalmember (a final rod). The second aperture also includes a second set offemale threads that accommodate a second compression member thatscrewably engages the second set of female threads, and the face of thesecond compression member contacts the second longitudinal member. Thereis a breakaway mechanism between the first and second apertures.

The rod-link reducer has a basic “H” shape that rigidly links and locksthe first longitudinal members (temporary rods). The rod-link reducerincludes: 1) two top-tightening locking mechanisms (break-off setscrews) which provide access and ensure the adequate grip on thetemporary rods by the set screws; 2) an adjustable central mechanismfunctioning in a multi-axial manner, allowing attachment to the rod atany orientation in the coronal, sagittal, and transverse planes, saidmechanism allowing for compression, distraction, derotation andcantilever method; 3) two adjustable lateral mechanisms (break-off setscrews) which allow the locking mechanisms to adequately attach to thetemporary rods; and 4) two squared ends that connect with two reductionhandles.

The reduction handle is a column shape and has two portion ends. Thefirst end has a squared access that connects with the squared end of therod-link reducer. The second end is a solid column. The temporary rodand the final rod are the diameter of 5.5 mm rods those are made ofstainless steel or titanium.

In operation, the present invention is used as follows: With the spineexposed posteriorly, the pedicle screw is inserted segmentally, exceptfor the resected levels (apex). The spine is then divided into cephaladand caudal portions by the resected levels. At the cephalad portion, twotemporary rods are fixed on the convex and concave side via the firstaperture of the pedicle screw respectively. Another two temporary rodsis then similarly fixed at the caudal portion. The two temporary rods onthe concave side are then connected with a rod-link reducer and lockedto the shape of the deformity without any attempt at correction.Resection of the vertebral column is then performed at the convex sideof the apex. Following resection on the convex side, another rod-linkreducer is connected and locked on the two convex temporary rods. Theresection of the remaining vertebra is then performed on the concaveside.

Deformity correction is performed by loosening the adjustable centralmechanism of the rod-link reducer on the convex side with the reductionhandles, which is then gradually compressed to shorten the resected gap.During the compression, the resected gap on the convexity, the centralpart of rod-link reducer on the concavity is gradually loosened to matchthe compression/shortening on the convexity.

After deformity correction, two final rods are fixed on the convex andconcave side via the second aperture of the pedicle screw respectively.The two rod-link reducers are then unlocked and all temporary rods areremoved. A custom wrench is then used to remove the first aperture partsof the pedicle screw.

The pedicle screw and any of its components including the bone fastener,threads, neck and screwhead, are comprised of a non-organic materialthat is durable and that can be implanted in a human body, such astitanium, stainless steel, spring steel, aluminum, Niobium, carbonfiber, ceramics, polymers, composites or any relatively hard material(e.g. Titanium-Aluminium-Niobium-alloy). Generally, the materialselected is biocompatible, that is, compatible with the surrounding boneand tissue.

The present invention provides a substantial improvement in addressingclinical problems indicated for surgical treatment of chronic or acutespinal injuries, including traumatic spinal injuries, scoliosis(abnormal lateral curvature of the spine), kyphosis (abnormal forwardcurvature of the spine, often in the thoracic spine), excess lordosis(abnormal backward curvature of the spine, often in the lumbar spine),spondylolisthesis (forward displacement of one vertebra over another,often in a lumbar or cervical spine) and other disorders caused byabnormalities, disease or trauma, such as ruptured or slipped discs,degenerative disc disease, fractured vertebra, and the like.

The present inventors recognize that there are other disadvantages ofthe current implant strategies used during Posterior Vertebral ColumnResection (PVCR) that have been overcome by designing a new pediclescrew posterior instrumentation system. The present invention includesscrews, methods, kits and systems that provide a safer, easier andbetter correction, as well as shorter operation time method, for thePVCR of the severe spinal deformity. The present invention takesadvantage of the top-loading and side-loading current designs as well asa universal connecting link to provide three-dimensional correction.These components provide: 1) continued stabilization of the spine duringbony resection as well as correction; 2) allow for controlled correctionof the spine using both rods; and 3) provide the ability to place thepermanent rods while the long provisional rod is in place so thatinstability is not created.

The present invention includes: 1) a pedicle screw with a screw headthat can receive two rods. The bone screw head includes tworod-receivers. One receiver member is basic “U” shape (top-loadingcomponent) that extends from the top of the screw head to receive atemporary rod. Another receiver member has a basic “C” shape(side-loading component) that is inferior to the first receiver. Thesecond receiver receives a final rod. There is also a breakawaymechanism between the first and second apertures so that the firstaperture can be removed while the final rod is fixed; 2) a rod-linkreducer has a basic “H” shape that rigidly links and locks the temporaryrods, which allows attachment to the rod at any orientation in thecoronal, sagittal, and transverse planes so as to make compression,distraction, derotation and cantilever method; 3) a reduction handlethat connects with the rod-link reducer; and 4) a 5.5 mm diameter rod.For the PVCR of severe spinal deformity, this instrumentation systemwould provide: 1) better maintenance of spinal stability throughout thesurgical procedure to reduce risk of the spinal cord injuries; 2) morereliable reconstruction of the vertebral column; 3) better and easiercorrection of the deformity; and 4) shorter operative time.

More particularly, the present invention includes a rod link reducer fora spinal fixation system. The rod link reducer includes a first and asecond spinal rod manipulator; a first spinal rod manipulator jointconnected to the first spinal rod manipulator and a second spinal rodmanipulator joint connected to the second spinal rod manipulator; afirst and a second translatable transverse shaft connected to the firstand second joints, respectively; and a universal reducer connected toboth the first and second translatable transverse shafts, wherein thereducer, the shafts and the linkers provide movement and temporaryfixation of a spine that has been manipulated into a final positionduring spinal surgery. In one aspect, the spinal rod manipulator isfurther defined as comprising a handle and a rod attachment fixationpoint, wherein the rod attachment fixation point at least partiallysurrounds a rod with a semi-permanent fastener. In another aspect, thefirst, the second or both the first and second translatable transverseshafts connects to the universal reducer and are capable of sliding toincrease or decrease the distance between the first and second joints.The universal reducer can be, for example, a ball joint, a universaljoint, a pivot, a slot, a collar, a bearing, a dove-tail, a ball-joint,a gimbal, a level, or a sleeve that permits movement of the translatabletransverse shafts in two or more dimensions. In another aspect, theuniversal reducer includes a fastener that semi-permanently fixes theposition of the reducer in relation to the first, the second or bothtranslatable transverse shafts. The first and second joints may eachinclude an independent fastener that semi-permanently fixes the relativeposition of the first spinal rod manipulator to the first translatabletransverse shaft, the second spinal rod manipulator to the secondtranslatable transverse shaft or both the first and second spinal rodmanipulator to the first and second translatable transverse shafts,respectively. Any component of the rod link reducer may be comprised oftitanium, stainless steel, spring steel, aluminum, Niobium and alloysthereof, carbon fiber, ceramics, polymers, composites, or combinationsthereof.

In another embodiment, the present invention includes a method ofcorrecting a spinal deformity by fastening two or more pedicle screwsinto two or more vertebra; interconnecting the pedicle screws with twoor more temporary rods; connecting a link reducer between the temporaryrods, the rod link reducer having a first and a second spinal rodmanipulator; a first spinal rod manipulator joint connected to the firstspinal rod manipulator and a second spinal rod manipulator jointconnected to the second spinal rod manipulator; a first and a secondtranslatable transverse shaft connected to the first and second joints,respectively; and a universal reducer connected to both the first andsecond translatable transverse shafts, wherein the reducer, the shaftsand the linkers provide movement and temporary fixation of a spine thathas been manipulated into a final position during spinal surgery. Next,the user correct the position of the spine by manipulating the temporaryrods attached to the pedicle screws; interconnects the pedicle screwswith a permanent fixation rod; and finally removes the temporary rod.One example of a pedicle screw for use with the present invention mayinclude a bone fastener and a rod coupling head, the rod coupling headcomprising a lower and an upper rod coupling: the lower rod couplingincluding a lateral rod opening adapted to receive a permanent rod; anangled bore extends into the lateral rod opening; and a permanent rodfastener in the angled bore to engage a permanent rod in the lateral rodopening; and a upper rod coupling having: an upper rod opening adaptedto receive a temporary rod, wherein the upper rod opening is formed toreceive a temporary rod fastener, wherein the upper rod coupling isdetachable from the lower rod coupling at a transition, wherein atemporary rod is temporarily affixed into the upper rod opening during abone realignment and a permanent rod is positioned in the lateral rodopening and engaged by the permanent rod fastener upon final bonealignment. In one aspect, the spinal rod manipulator is further definedas comprising a handle and a rod attachment fixation point, wherein therod attachment fixation point at least partially surrounds a rod with asemi-permanent fastener. In another aspect, the first, the second orboth the first and second translatable transverse shafts connect to theuniversal reducer and are capable of sliding to increase or decrease thedistance between the first and second joints. The universal reducer mayinclude a ball joint, a universal joint, a pivot, a slot, a collar, abearing, a dove-tail, a ball-joint, a gimbal, a level, or a sleeve thatpermits movement of the translatable transverse shafts in two or moredimensions. In another aspect, the universal reducer may include afastener that semi-permanently fixes the position of the reducer inrelation to the first, the second or both translatable transverseshafts. The first and second joints may each include an independentfastener that semi-permanently fixes the relative position of the firstspinal rod manipulator to the first translatable transverse shaft, thesecond spinal rod manipulator to the second translatable transverseshaft, or both the first and second spinal rod manipulator to the firstand second translatable transverse shafts, respectively.

The present invention also includes a kit that includes a rod linkreducer of a spinal fixation system, the rod link reducer having a firstand a second spinal rod manipulator; a first spinal rod manipulatorjoint connected to the first spinal rod manipulator and a second spinalrod manipulator joint connected to the second spinal rod manipulator; afirst and a second translatable transverse shaft connected to the firstand second joints, respectively; and a universal reducer connected toboth the first and second translatable transverse shafts, wherein thereducer, the shafts and the linkers provide movement and temporaryfixation of a spine that has been manipulated into a final positionduring spinal surgery. The kit may also include two or more pediclescrews into two or more vertebra, the pedicle screw including a bonefastener and a rod coupling head, the rod coupling head comprisingseparate lower and upper lower rod couplings: the lower rod couplingincluding: a lateral rod opening adapted to receive a permanent rod; anangled bore extends into the lateral rod opening; and a permanent rodfastener in the angled bore to engage a permanent rod in the lateral rodopening; and a upper rod coupling including: an upper rod openingadapted to receive a temporary rod, wherein the upper rod opening isformed to receive a temporary rod fastener; and two or more temporaryrod fasteners. The kit may also include at least one of two or morepermanent rods, two or more temporary rods, one or more rod linkreducers, a plurality of pedicle screws and one or more leveragehandles.

FIG. 1 shows one embodiment of the pedicle screw 10 of the presentinvention. The pedicle screw 10 includes a bone fastener 12 and a rodcoupling head 14. The rod coupling head 14 includes a lower rod coupling16 having a lower rod opening 18, depicted in a lateral configuration.The lower rod opening 18 may have any angle so long as the material ofthe pedicle screw 10 that surrounds the lower rod opening 18 issufficiently strong to retain and affix a permanent rod. The lower rodcoupling 16 also includes a bore 20, through which a permanent rodfastener 22 can be inserted to fasten a permanent rod. As in the case ofthe lower rod opening 18, the material of the pedicle screw 10surrounding the bore 20 will also be sufficiently strong to retain andaffix a permanent rod. The upper rod coupling 24 has an upper rodopening 26. The upper rod coupling 24 is formed to permit the user toinsert a temporary rod using a temporary rod fastener 28. The lower andupper rod couplings 16 and 24, respectively will often be made ofunitary construction. For illustration purposes, and not necessarily asan element or limitation, a transition 32 is denoted. In unitaryembodiments, the transition 32 may be modified (e.g., notched, cut,scratched or weakened) to provide for the breakage of the upper rodcoupling 24. In another embodiment, the transition 32 may provide asemi-permanent attachment between the lower rod coupling 16 and theupper rod coupling 24, such that the transition is a universal joint, apivot, a slot, a collar, a bearing, a dove-tail, a ball-joint, a gimbal,a level, or a sleeve. Likewise, the lower rod coupling 16 and the bonefastener may be connected with a universal joint, a pivot, a slot, acollar, a bearing, a dove-tail, a ball-joint, a gimbal, a level, or asleeve. When made in a unitary construction, the pedicle screw 10 may bemachined, sintered, cast, welded or glued as long as the pedicle screwis of sufficient strength for the bone fixation application.

FIGS. 2A to 2C show a cross-sectional view of the pedicle screw 10 inoperation. In FIG. 2A, the pedicle screw has been affixed to a bone (notdepicted), and a temporary rod 34 has been inserted into the upper rodopening 26 and semi-permanently affixed using the temporary rod fastener28. In the embodiment depicted, the upper rod opening 26 is showninternally threaded, and the temporary rod fastener 28 is shownexternally threaded. The skilled artisan will recognize that the presentinvention also includes fastener embodiments in which the threading isreversed, the threading is external to the upper rod coupling, and thefastener is internally threaded, the fastener is a cap, the fastener andthe coupling snap together, are wedged together, twist and lock.Likewise, the permanent rod fastener is also able to engage thepermanent rod in a variety of manners, including pins, latches,threading, snapping, wedging and locking. The permanent rod may even beglued or welded.

FIG. 2B shows the addition of the permanent rod 36 in addition to thetemporary rod 34. Next, the temporary rod fastener 28 and the temporaryrod are removed (not depicted). Finally, FIG. 2C shows the finalassembly in which the upper rod coupling is removed completely bybreaking the upper rod coupling into tabs 40 at breakpoints 38.

FIGS. 3A and 3B shows an isometric view and a cross-sectional view,respectively, of the pedicle screw 10 in which the lower rod coupling 16and the upper rod coupling 24 are connected, and in which a screwportion 50 is fastened into opening 52, allowing the potential for somerotations about the axis of the screw portion 50. After the permanentrod has been affixed into the pedicle screw 10, the upper rod fastener24 is removed.

FIGS. 3A and 3B show an isometric view and a cross-sectional view,respectively, of the pedicle screw 10 in which the lower rod coupling 16and the upper rod coupling 24 are connected, and in which a screwportion 50 is fastened into opening 52, allowing the potential for somerotations about the axis of the screw portion 50. After the permanentrod has been affixed into the pedicle screw 10, the upper rod fastener24 is removed.

FIGS. 4A and 4B show an isometric view and a cross-sectional view,respectively, of the pedicle screw 10 in which the lower rod coupling 16and the upper rod coupling 24 are connected by and in which a screw 54is fastened through opening 56 into opening 52 and which permits thepotential for some rotations about the axis of the screw 54. After thepermanent rod has been affixed into the pedicle screw 10, the upper rodfastener 24 is removed by unscrewing screw 54. The screw 54 also permitscontrol over the mechanical force required to rotate the upper rodcoupling 24. For configurations in which the lower rod coupling 16 andthe upper rod coupling 24 are separate, the interface between the twomay be smooth, rough or patterned (e.g., random or non-random) orcoated.

FIGS. 5A and 5B show an isometric view and a cross-sectional view,respectively, of the pedicle screw 10 in which the lower rod coupling 16and the upper rod coupling 24 are connected by and in which a screw 54is fastened through opening 56 into opening 52 and which permits thepotential for some rotations about the axis of the screw 54. After thepermanent rod has been affixed into the pedicle screw 10, the upper rodfastener 24 is removed by unscrewing screw 54. In this configuration thelower rod coupling 16 and the upper rod coupling 24 are separate and theinterface between the upper and lower rod couplings (24, 16) is enhancedby the addition of an opening 60 that dove-tails with a notch 62. Thenotch 62 can even be placed at an angle or can also be made square suchthat the upper rod coupling 24 can be placed parallel or perpendicularto the direction of the permanent or temporary rods.

FIGS. 6A and 6B show an isometric view and a cross-sectional view,respectively, of the pedicle screw 10 in which the lower rod coupling 16and the upper rod coupling 24 are connected by and in which a screw 54is fastened through opening 56 into opening 52 and which permits thepotential for some rotations about the axis of the screw 54. After thepermanent rod has been affixed into the pedicle screw 10, the upper rodfastener 24 is removed by unscrewing screw 54. In this configuration thelower rod coupling 16 and the upper rod coupling 24 are separate and theinterface between the upper and lower rod couplings (24, 16) is enhancedby the addition of a slit 60 that dove-tails with an external notch 62.The notch 62 can even be placed at an angle or can also be made squaresuch that the upper rod coupling 24 can be placed parallel orperpendicular to the direction of the permanent or temporary rods.

FIGS. 7A and 7B show an isometric view and a cross-sectional view,respectively, of the pedicle screw 10 in which the lower rod coupling 16and the upper rod coupling 24 are connected by and in which a screw 54is fastened through opening 56 into opening 52 and which permits thepotential for some rotations about the axis of the screw 54. After thepermanent rod has been affixed into the pedicle screw 10, the upper rodfastener 24 is removed by unscrewing screw 54. In this configuration thelower rod coupling 16 and the upper rod coupling 24 are separate and theinterface between the upper and lower rod couplings (24, 16) is enhancedby the addition of dove-tail joints (shown in two differentconfigurations). The notch 62 can even be placed at an angle or can alsobe made square such that the upper rod coupling 24 can be placedparallel or perpendicular to the direction of the permanent or temporaryrods.

FIG. 8 is an isometric view of a rod link reducer 100 for use with thepresent invention. The rod link reducer 100 includes first and secondspinal rod manipulators 102, 104, which are connected to a first spinalrod manipulator joint 106 connected to the first spinal rod manipulator102 and a second spinal rod manipulator joint 108 connected to thesecond spinal rod manipulator 104. First and second translatabletransverse shafts 110, 112 connected to the first and second joints 106,108, respectively, which are connected to a reducer 114 connected toboth the first and second translatable transverse shafts 110, 112,wherein the reducer 114, the shafts 110, 112 and the linkers 106, 108provide movement and temporary fixation of a spine that has beenmanipulated into a final position during spinal surgery.

FIG. 9 is a cross-sectional side view of one embodiment of the rod linkreducer 10 present invention, shown in this embodiment with screws 116.The skilled artisan will recognize that the screws 16 provide reversiblemechanical fixation between the different parts of the system that canbe tightened and loosened during spinal adjustments. Any given joint mayinclude some friction or resistance during use up to and including totalfixation. The screws 116 can be replaced or include pins, set screws,cotter pins, internal or external compression, compression fittings,collared fittings, screw-drives or even electrical, pneumatic orhydraulic movement or pressure. In the embodiment depicted, first andsecond translatable transverse shafts 110, 112 as shown as adjustmentsleeves slidably fitted within a housing 118 is an axial bore 120 andwithin the axial bore a strut 122 in which the screw 116 serves as afastener positioned to secure the strut 122 within the housing 118,wherein the struts 112 allow for coarse longitudinal movement of thestrut 122 with respect to the strut housing 118. The skilled artisanwill recognize that the strut-bore configuration can be reversed(bore-strut) or replaced with side-by-side struts, internal-externalslidable pins within a groove, screw-drives, magnetic drives,electrical, pneumatic or hydraulic drives so long as the translatabletransverse shafts 110, 112 permit the user to expand and/or contract oneor both the translatable transverse shafts 110, 112.

FIG. 10 is a side view of one embodiment of rod manipulators 102, 104.In this side view, screws 116 are shown as well as either first orsecond joint 106, 108. The rod manipulators 102, 104 include a head 130that has an opening 132 that first a rod (temporary or permanent) forspinal fixation. The screw 116 is used to engage and retain the rod. Therod manipulators 102, 104 are comprised of a material with sufficienttensile strength to allow the manipulator to fasten to the rod but alsoto permit the user to translate movement from the handle 134 into therod in any direction. The handle 134 may itself also include a coating(not depicted) to improve the grip of a user during use or may be shapedto permit a second handle to attach to the handle 134 to increase theleverage of a user when manipulating a spine during spinal fixationsurgery. Again, while this embodiment is shown with screws, anyfastening method (pins, set-screws, compression, collets, etc.) may beused to fasten the various components of the rod link reducer of thepresent invention.

The rod link reducer 100 may be used in conjunction with existing spinalscrew and rod fixation systems or may be used in conjunction with thepedicle screw 10. The size and thickness of rods may be varied dependingon the type of surgery, tensile strength required and preference of theuser.

FIG. 11 shows the first step in a spinal fixation process. In thisembodiment, a temporary rod 34 has been attached to pedicle screws 10(while not depicted, the pedicle screws may be attached individualvertebra. Examples of conditions that may be treated using the presentinvention include kyphosis, lordosis, scoliosis or combinations thereof.A rod link reducer 100 is shown connected to the temporary rod 34 andthe spine (not shown) has been aligned. In FIG. 12, the permanent rod 36is introduced into the pedicle screw 10 while the rod link reducer 110holds the entire assembly in place while the permanent rod ispermanently affixed to the pedicle screws 10. Finally, FIG. 13 shows thefinal spinal rod assembly after removing the temporary rod and thebreakable tabs from the pedicle screws 10.

FIG. 14 shows the advantage provided by the rod link reducer 100 of thepresent invention. In this top view of the operation of the presentinvention, two rod link reducers 100 a, 100 b are connected to two pairsof temporary rods 34 a-d and pedicle screws 10 a-h. By compressing,distracting or rotating the rod link reducers 100 a, 100 b, the user canmanipulate the spine in all directions necessary for spinal alignmentand fixation. Furthermore, the user is able to compress, distract, andtranslate any of the spinal segments until arriving at a final position.The rod link reducer 100 is tightened upon final positioning and thepermanent rod can be inserted into the pedicle screws. Furthermore, therod link reducers 100 a, 100 b can be tightened in a single plane at atime while still manipulating the rest of the spine in the other planes.

The present invention can be used to correct mild to severe spinaldeformities, including sever deformities. The present invention includesthe following advantages: a reduced risk of intraoperative mishaps dueto the instability caused by exchanging the temporary rods with thepermanent rod, it increases the directions in which the deformities canbe corrected and reduces the number of tools, and surgical time causedby temporary rod failure or slipping that occurs between the finalpositioning of the temporary rods and the fixation of the permanent rod.It has been found that the present invention allows the surgeon toshorten the duration of the operation and also increases the extent ofcorrection in a single procedure.

FIG. 15 shows an overlay of the planning and tools for a surgicalprocedure to correct a severe spinal deformity. An x-ray is shown of amalformed spine and the tools are overlaid to plan the positioning ofthe pedicle screws, rods and rod link reducer. Next, the user determinesthe various different steps in the correction, including thecompression, distraction, apical derotation and translation of one orboth pairs of temporary rods. Also shown are optional tools or handlesto increase the leverage of the surgeon, taking into account theaccessibility of tools due to the translation and rotation of theunderlying spine prior to treatment. In certain cases, the steps may bealternated to maximize the leverage of the rod link reducers indifferent direction, thereby maximizing efficiency of the movement,increasing the effectiveness of the procedure and minimizing the time ofthe procedure.

FIGS. 16A to 16E shows a procedure of the present invention thatincludes distraction, translation and apical derotation. FIG. 16A showsa single right thoracic rigid curve 200. FIG. 16B shows the first stepin the procedure in which temporary rods 34 a and 34 b, which are fixedat a proximal portion of the spine and another one fixed at distalportion of the curve about a concavity. The temporary rods 34 a, 34 bare attached to the single right thoracic rigid curve 200 using pediclescrews (not depicted) on either end of the site for distraction,translation and apical derotation. One example of the pedicle screwsthat may be used in the procedure is pedicle screw 10. FIG. 16C showsthe rod link reducer 100 connected to temporary rods 34 a and 34 b onthe concavity. Next, derotation instruments 202 a-c are attached to theapical vertebrae. FIG. 16D shows the combined distraction, translationand apical derotation of the spine in which the rod link reducer 100 isused for the distraction and translation (arrows) and the derotationinstruments 202 a-c, seen as a cross-sectional view of the spine at avertebrae 304, are used alone or in combination (in this instance) forapical derotation via linker 308 attached to pedicle screws 310. Theskilled artisan will recognize that these tools may be used for adistraction, translation and/or apical rotation, however, mostprocedures will involve combinations of these manipulations. FIG. 16Eshows a variation of the combined distraction, translation and apicalderotation outlined in FIGS. 16A-16D in which pairs of temporary rods 34a, 34 b are shown in parallel along the proximal and distal segments ofthe spine. A second rod link reducer 101 is shown as two provisionalrods 34 are on the concavity. Convex provisional compression is to helpthe curve correction.

FIGS. 17A to 17E shows the use of the rod link reducer 100 on a spinalconvexity. FIG. 17A shows a double major rigid curve 300 onto which twotemporary rods 34 a, 34 b are on the concavity of the thoracic curve andtwo temporary rods 34 c, 34 d are on the concavity of the lumbar curve.FIG. 17C shows the attachment of two rod-link reducers 100 fixed on theconcavity for both curves, respectively. Next, the combined distraction,translation and apical derotation for both curves is depicted in whichderotation instruments 202 a-c and 202 d-e are attached to the vertebrae304, 305 through pedicle screws 306 via linkers 308. The linkers 308serve as attachment points for the derotation instruments 202 a-e andcan be used to increase the leverage for the distraction, translationand apical derotation. FIG. 17E shows the positioning of a pair ofconvex temporary rods at each site used for compression maneuvers tohelp in the correction of the two curves using two rod link reducer 100,101 about each of the treatment sites.

FIG. 18 is a detailed view of one embodiment of an apical derotationwithout linking the two pedicle screws 310 a,b. In this embodiment, thelinkers 308 a,b are used directly to aid in the apical rotation of asingle vertebrae 304 without a linked derotation instrument.

FIGS. 19, 20 and 21 shows various designs of the rod-link reducer 100.FIG. 19 shows a rod link reducer 100 that includes a universal connecteron the central portion. The rod link reducer 100 includes first andsecond spinal rod manipulators 102, 104, which are connected to a firstspinal rod manipulator joint 106 connected to the first spinal rodmanipulator 102 and a second spinal rod manipulator joint 108 connectedto the second spinal rod manipulator 104. First and second translatabletransverse shafts 110, 112 slides through joints 106, 108, respectively.The joints 106, 108 can tighten to fix the transverse shafts 110, 112individually. In FIG. 19, the two translatable transverse shafts 110,112 have movement around a reducer 114, which is depicted as a singlereducer with universal movement. In one example, the reducer 114 may befixed to act as a straight rod to limit the movement of the first andsecond spinal rod manipulators 102, 104 in two planes. FIGS. 20 and 21show the rotation between the rod-connecter. This design is stronger andeasy to install, and give surgeons more freedom during surgery.

As the skilled artisan will appreciate, the first and secondtranslatable transverse shafts 110, 112 may be in-line, as depicted inFIGS. 19-21, or may be parallel on two separate planes allowing thefirst and second translatable transverse shafts to extend past the endsof the opposite shaft. By allowing the first and second translatabletransverse shafts to move in parallel, the distance between first andsecond spinal rod manipulators 102, 104 can be reduced to a minimum incertain manipulations. As can also be seen from these figures, the firstand second rod manipulator joints 106, 108 can slide toward or away fromthe temporary rods 34 a,b. The configuration presented herein allows sixdegrees of freedom in any direction, while also providing the necessarystrength and leverage to perform complex spinal deformity surgery in areduced space.

FIG. 22A to 22C shows the new pedicle screw and apical rod-link reducerposterior instrumentation system that includes: (A) pedicle screw with ascrew head that can receive two 5.5-mm rods (provisional and final rods)with a breakaway mechanism between the two rod-receivers; and (B) arod-link reducer rigidly linking the provisional rods at the apex,allowing attachment to the rod at any orientation so as to easily makecompression, distraction, derotation and cantilever maneuver. While thedeformity is corrected using the provisional rod/rod-link reducer, thefinal rod is fixed and then the provisional ones are removed. Asix-segment plastic spine model was instrumented to model threeconstructs: (A) provisional rod/apical rod-link reducer; (B) provisionalrod; and (C) final rod. The spines were tested using pure bendingmotions. Segmental range of motion (ROM) was recorded using athree-dimensional motion analysis system.

FIG. 23 is a drawing illustrating a perspective view of the rod-linkreducer 100 which links and locks the first and second translatabletransverse shafts 110,112. The reducer 114 provides a mechanism torotate the device on the concavity. For example, the reducer 114 canhave a ball bearing like mechanism controlled by the screw 116 as seenin FIG. 23. FIG. 24 is a drawing illustrating a perspective view of therod-link reducer 100 which links and locks the first and secondtranslatable transverse shafts 110,112. The reducer 114 provides amechanism to rotate the device on the convexity.

FIGS. 25 and 26 are diagrams illustrating perspective views of the partsof the rod-link reducer 100. Specifically, FIG. 25 shows the first andsecond translatable transverse shafts 110,112, and the reducer 114 andthe screw 116. FIG. 26 shows the parts of the either first or secondjoint 106,108.

FIG. 27 is a diagram showing the combination of parts from FIGS. 25 and26 with the first and second translatable transverse shafts 110,112,reducer 114, the screw 116, and either first or second joint 106,108.

FIG. 28 is a diagram similar to FIG. 10 with a side view of oneembodiment of rod manipulators 102,104. In this side view screws 116 areshown as well as either first or second joint 106,108. The rodmanipulators 102,104 include a head 130 that has an opening 132 thatfirst a rod (temporary or permanent) for spinal fixation. The screw 116is used to engage and retain the rod. In particular, the cross sectionsof the either first or second joint 106,108 are shown.

FIG. 29 is an image of two rod-link reducers 100 a,100 b which links andlocks the first and second translatable transverse shafts 110 a,b and112 a,b. The reducer 114 a,b provides a mechanism to rotate the deviceon the concavity. For example, the reducer 114 can have a ball bearinglike mechanism controlled by the screw 116 a,b. The rod link reducer 100a,b includes first and second spinal rod manipulators 102 a,b and 104a,b, which are connected to a first spinal rod manipulator joint 106 a,bconnected to the first spinal rod manipulator 102 a,b and a secondspinal rod manipulator joint 108 a,b connected to the second spinal rodmanipulator 104 a,b. First and second translatable transverse shafts 110a,b, 112 a,b slides through joints 106 a,b, 108 a,b, respectively. Thejoints 106 a,b and 108 a,b can tighten to fix the transverse shafts 110a,b and 112 a,b individually. The two translatable transverse shafts 110a,b, 112 a,b have movement around the reducer 114 a,b, which is depictedas a single reducer with universal movement. The first and second spinalrod manipulators 102 a,b and 104 a,b are connected to the temporary rods34 a,b,c,d,e,f,g,h,i,j,k,ld affixed to the pedicle screws 10a,b,c,d,e,f,g,h,i,j,k,l in the spine for alignment.

FIG. 30 is an image of two rod-link reducers 100 a,b which link and lockthe first and second translatable transverse shafts 110 a,b and 112 a,bshowing the reducers correcting the coronal curve. The reducers 114 a,bprovide a mechanism to rotate the device on the concavity. For example,the reducer 114 can have a ball bearing like mechanism controlled by thescrew 116 a,b. The rod link reducer 100 a,b includes first and secondspinal rod manipulators 102 a,b and 104 a,b, which are connected to afirst spinal rod manipulator joint 106 a,b connected to the first spinalrod manipulator 102 a,b and a second spinal rod manipulator joint 108a,b connected to the second spinal rod manipulator 104 a,b. First andsecond translatable transverse shafts 110 a,b, 112 a,b slides throughjoints 106 a,b, 108 a,b, respectively. The joints 106 a,b and 108 a,bcan tighten to fix the transverse shafts 110 a,b and 112 a,bindividually. The two translatable transverse shafts 110 a,b, 112 a,bhave movement around the reducer 114 a,b, which is depicted as a singlereducer with universal movement. The first and second spinal rodmanipulators 102 a,b and 104 a,b are connected to the temporary rods 34a,b,c,d,e,f,g,h,i,j,k,ld affixed to the pedicle screws 10a,b,c,d,e,f,g,h,i,j,k,l in the spine for alignment.

FIG. 31 is an image that shows the rod-link-reducers and the provisionalrods and the final rods with the spine which is corrected. The reducer114 a,b provides a mechanism to rotate the device on the concavity. Forexample, the reducer 114 can have a ball bearing like mechanismcontrolled by the screw 116 a,b. The rod link reducer 100 a,b includesfirst and second spinal rod manipulators 102 a,b and 104 a,b, which areconnected to a first spinal rod manipulator joint 106 a,b connected tothe first spinal rod manipulator 102 a,b and a second spinal rodmanipulator joint 108 a,b connected to the second spinal rod manipulator104 a,b. First and second translatable transverse shafts 110 a,b, 112a,b slides through joints 106 a,b, 108 a,b, respectively. The joints 106a,b and 108 a,b can tighten to fix the transverse shafts 110 a,b and 112a,b individually. The two translatable transverse shafts 110 a,b, 112a,b have movement around the reducer 114 a,b, which is depicted as asingle reducer with universal movement. The first and second spinal rodmanipulators 102 a,b and 104 a,b are connected to the temporary rods 34a,b,c,d,e,f,g,h,i,j,k,ld affixed to the pedicle screws 10a,b,c,d,e,f,g,h,i,j,k,l in the spine for alignment. In addition to thetemporary rods 34 a,b,c,d,e,f,g,h,i,j,k,ld, permanent rods 36 a,b areintroduced into the pedicle screws 10 a,b,c,d,e,f,g,h,i,j,k,l while therod link reducers 100 a,b holds the entire assembly in place. FIG. 31shows the permanent rods 36 a,b with the temporary rods 34a,b,c,d,e,f,g,h,i,j,k,ld and the rod link reducers 100 a,b in position.

FIG. 32 is an image that shows the final rods with the spine which iscorrected. FIG. 32, the permanent rods 36 a,b are introduced into thepedicle screws 10 a,b,c,d,e,f,g,h,i,j,k,l while the rod link reducer(not shown) holds the entire assembly in place while the permanent rods36 a,b are permanently affixed to the pedicle screws 10a,b,c,d,e,f,g,h,i,j,k,l. FIG. 32 shows the final spinal rod assemblyafter removing the temporary rods (not shown) and the breakable tabsfrom the pedicle screws 10 a,b,c,d,e,f,g,h,i,j,k,l.

FIG. 33 is an image that shows the rod-link-reducers correct thesagittal curve to the normal kyphosis. The reducer 114 a,b provides amechanism to rotate the device. For example, the reducer 114 can have aball bearing like mechanism controlled by the screw 116 a,b. The rodlink reducer 100 a,b includes first and second spinal rod manipulators102 a,b and 104 a,b, which are connected to a first spinal rodmanipulator joint 106 a,b connected to the first spinal rod manipulator102 a,b and a second spinal rod manipulator joint 108 a,b connected tothe second spinal rod manipulator 104 a,b. First and second translatabletransverse shafts 110 a,b, 112 a,b slides through joints 106 a,b, 108a,b, respectively. The joints 106 a,b and 108 a,b can tighten to fix thetransverse shafts 110 a,b and 112 a,b individually. The two translatabletransverse shafts 110 a,b, 112 a,b have movement around the reducer 114a,b, which is depicted as a single reducer with universal movement. Thefirst and second spinal rod manipulators 102 a,b and 104 a,b areconnected to the temporary rods 34 a,b,c,d,e,f,g,h,i,j,k,ld affixed tothe pedicle screws 10 a,b,c,d,e,f,g,h,i,j,k,l in the spine foralignment.

FIG. 34 is an image that shows the rod-link-reducers correct thesagittal curve to the normal lordosis. The reducer 114 a,b provides amechanism to rotate the device. For example, the reducer 114 can have aball bearing like mechanism controlled by the screw 116 a,b. The rodlink reducer 100 a,b includes first and second spinal rod manipulators102 a,b and 104 a,b, which are connected to a first spinal rodmanipulator joint 106 a,b connected to the first spinal rod manipulator102 a,b and a second spinal rod manipulator joint 108 a,b connected tothe second spinal rod manipulator 104 a,b. First and second translatabletransverse shafts 110 a,b, 112 a,b slides through joints 106 a,b, 108a,b, respectively. The joints 106 a,b and 108 a,b can tighten to fix thetransverse shafts 110 a,b and 112 a,b individually. The two translatabletransverse shafts 110 a,b, 112 a,b have movement around the reducer 114a,b, which is depicted as a single reducer with universal movement. Thefirst and second spinal rod manipulators 102 a,b and 104 a,b areconnected to the temporary rods 34 a,b,c,d,e,f,g,h,i,j,k,ld affixed tothe pedicle screws 10 a,b,c,d,e,f,g,h,i,j,k,l in the spine foralignment. The skilled artisan will recognize that the instant inventionmay be used to correct all forms of alignments including kyphosis andlordosis.

FIG. 35 is an image that shows the pedicle screws, provisional rods, andtwo rod-link-reducers are fixed in a sagittal curve deformity model. Thereducer 114 a,b provides a mechanism to rotate the device. For example,the reducer 114 can have a ball bearing like mechanism controlled by thescrew 116 a,b. The rod link reducer 100 a,b includes first and secondspinal rod manipulators 102 a,b and 104 a,b, which are connected to afirst spinal rod manipulator joint 106 a,b connected to the first spinalrod manipulator 102 a,b and a second spinal rod manipulator joint 108a,b connected to the second spinal rod manipulator 104 a,b. First andsecond translatable transverse shafts 110 a,b, 112 a,b slides throughjoints 106 a,b, 108 a,b, respectively. The joints 106 a,b and 108 a,bcan tighten to fix the transverse shafts 110 a,b and 112 a,bindividually. The two translatable transverse shafts 110 a,b, 112 a,bhave movement around the reducer 114 a,b, which is depicted as a singlereducer with universal movement. The first and second spinal rodmanipulators 102 a,b and 104 a,b are connected to the temporary rods 34a,b,c,d,e,f,g,h,i,j,k,ld affixed to the pedicle screws 10a,b,c,d,e,f,g,h,i,j,k,l in the spine for alignment.

FIG. 36 is an image that shows the final rod insertion after thesagittal curve correction. FIG. 36 is an image that shows therod-link-reducers and the provisional rods and the final rods with thespine which is corrected. The reducer 114 a,b provides a mechanism torotate the device on the concavity. For example, the reducer 114 canhave a ball bearing like mechanism controlled by the screw 116 a,b. Therod link reducer 100 a,b includes first and second spinal rodmanipulators 102 a,b and 104 a,b, which are connected to a first spinalrod manipulator joint 106 a,b connected to the first spinal rodmanipulator 102 a,b and a second spinal rod manipulator joint 108 a,bconnected to the second spinal rod manipulator 104 a,b. First and secondtranslatable transverse shafts 110 a,b, 112 a,b slides through joints106 a,b, 108 a,b, respectively. The joints 106 a,b and 108 a,b cantighten to fix the transverse shafts 110 a,b and 112 a,b individually.The two translatable transverse shafts 110 a,b, 112 a,b have movementaround the reducer 114 a,b, which is depicted as a single reducer withuniversal movement. The first and second spinal rod manipulators 102 a,band 104 a,b are connected to the temporary rods 34 a,b,c,d affixed tothe pedicle screws 10 a,b,c,d,e,f,g,h,i,j,k,l in the spine foralignment. In addition to the temporary rods 34 a,b,c,d, permanent rod36 are introduced into the pedicle screws 10 a,b,c,d,e,f,g,h,i,j,k,lwhile the rod link reducers 100 a,b holds the entire assembly in place.FIG. 36 shows the permanent rod 36 with the temporary rods 34 a,b,c,dand the rod link reducers 100 a,b in position.

FIG. 37 is an image that shows the final rods are with the spine whichis corrected. FIG. 37, the permanent rod 36 are introduced into thepedicle screws 10 a,b,c,d,e,f,g,h,i,j,k,l while the rod link reducer(not shown) holds the entire assembly in place while the permanent rod36 are permanently affixed to the pedicle screws 10a,b,c,d,e,f,g,h,i,j,k,l. FIG. 37 shows the final spinal rod assemblyafter removing the temporary rods (not shown) and the breakable tabsfrom the pedicle screws 10 a,b,c,d,e,f,g,h,i,j,k,l.

It was found that while using the present invention, there were nosignificant differences in the ROM between the three constructs exceptright lateral bending in which the provisional rod/rod-link and theprovisional rod constructs ROM were greater than the final rod construct(P=0.005) (Table 1).

TABLE 1 Range of Motion (Degree) in the Three Constructs ProvisionalRod + Rod Link Provisional Rod Final Rod Flexion 4.3 ± 1.7 3.1 ± 0.2 3.2± 0.5 Extension 1.3 ± 0.1 1.2 ± 0.3 1.8 ± 0.6 Left Lateral Bending 1.8 ±0.8 1.9 ± 1   2.1 ± 0.6 Right Lateral Bending* 2.2 ± 0.3 2.3 ± 0.5 1.6 ±0.1 *ANOVA P-Value = 0.005, Provisional Rod + Rod Link and ProvisionalRod Construct ROM > Final Rod Construct.

The provisional rod/rod-link reducer construct provided similarstiffness and stability compared to the provisional and final rodconstructs. This new system offers a safer, easier and improveddeformity correction, as well as shorter surgical time for the PVCR ofthe severe spinal deformity.

The novel pedicle screw/rod-link reducer offers better maintenance ofspinal stability throughout the surgical procedure to reduce risk of thespinal cord injuries. This system therefore provides a safer, easier andimproved deformity correction, as well as shorter surgical time for thePVCR of the severe spinal deformity.

The present invention overcomes the following disadvantages of existingsystems, namely, the limitation for the apical vertebral derotation andtranslation. Another disadvantage of existing systems is the difficultyfor concave rod derotation and/or translation which result in pediclescrew loosening with damage to the spinal cord. The present inventionovercomes both of these advantages by providing a stable, sturdyplatform for use of temporary and permanent rods using a single pediclescrew. The pedicle screw of the present invention maximizes thestructural-mechanical properties of each fixation point (the lowerversus the upper rod coupling) for each specific type of rod (permanentor temporary) while at the same time maximizing the efficiency of thesurgical procedure with less tools and equipment. Furthermore, surgeonsare already familiar with similar tools and fasteners and do not need tolearn new procedures, techniques or the use of new tools.

The present invention provides short provisional or temporary rods usedto acquire purchase to the spinal column. The rods are attached to thevertebrae above and below the area of deformity via pedicle screws. Toconvey three dimensional corrective forces to the spine, the links mustattach securely and rigidly to the provisional rods. Freedom of motionin any plane cannot be tolerated. Therefore, a simple slot or hole inthe links that captures the provisional rod is not sufficient.

FIGS. 38A and 38B are images of different embodiments of the presentinvention that show the rigid mechanical connection between theprovisional rods and the links. FIGS. 38A and 38B illustrate thetemporary rods 34 a-34 d attached to pedicle screws 10 a-10 h. FIG. 38Ais an image of a rod manipulator 102 positioned between pedicle screws10 a and 10 b. The rod manipulator 102 includes a head 130 that has anopening not shown to connect to the temporary rod 34 a, and screw 116 isused to engage and retain the temporary rod 34 a. FIG. 38B is an imageof a rod manipulator 104 surrounding pedicle screw 10 c. The rodmanipulator 102 includes a head 130 having a first jaw 200 and a secondjaw 202 separated by jaw aperture 204. The first jaw 200 includes afirst rod coupling aperture 206 connected to the temporary rod 34 b andscrew 116 a is used to engage and retain the temporary rod 34 b. Thesecond jaw 202 includes a second rod coupling aperture 208 connected tothe temporary rod 34 b and screw 116 b is used to engage and retain thetemporary rod 34 b.

FIG. 39 is a top view of one embodiment of the present invention thatshows the rigid mechanical connection between the provisional rods andthe links. This embodiment of attachment is efficient and compact butdoes not permit attachment of the link to the provisional rod after therod has been attached to the pedicle screws. A rod manipulator 102 isshown positioned between pedicle screws 10 a and 10 b. Each of thepedicle screws 10 a and 10 b includes a bone fastener 12 a,b and a rodcoupling head 14 a,b. The rod coupling head 14 a,b includes a lower rodcoupling 16 a,b having a lower rod opening 18 a,b, depicted in a lateralconfiguration. The lower rod opening 18 may have any angle so long asthe material of the pedicle screw 10 a,b that surrounds the lower rodopening 18 a,b is sufficiently strong to retain and affix a permanentrod. The lower rod coupling 16 a,b also includes a bore 20 a,b, throughwhich a permanent rod fastener 22 a,b can be inserted to fasten apermanent rod 34. As in the case of the lower rod opening 18 a,b, thematerial of the pedicle screws 10 a and 10 b surrounding the bore 20 a,bwill also be sufficiently strong to retain and affix a permanent rod.The rod manipulator 102 includes a head 130 that has an opening (notshown) to connect to the temporary rod 34, and screw 116 is insertedinto bore 20 c to engage and retain the temporary rod 34. The rodmanipulator 102 is made from a material with sufficient tensile strengthto allow the manipulator to fasten to the rod but also to permit theuser to translate movement into the rod in any direction. Again, whilethis embodiment is shown with screws, any fastening method (pins,set-screws, compression, collets, etc.) may be used to fasten thevarious components of the rod link reducer of the present invention. Inthis embodiment, the link cannot be removed from the provisional rodwithout removing the provisional rod from the screws. This is the mostexpedient way to remove the link and rod when they are no longer needed,such as in preparation for placement of the final rod.

FIG. 40 is a bottom side view of one embodiment of the rod manipulator102. In this view, screw 116 is shown, as well as first joint 106. Thisembodiment allows the attachment of a link that has already been securedto the spine. The rod manipulator 102 includes a head 130 that has anopening 132 that first a rod 34 for spinal fixation. The screw 116 a inaperture 20 c is used to engage and retain the rod 34. The rodmanipulator 102 includes a body portion 133 that includes the firstjoint 106. The first joint 106 includes an aperture (not shown) toaccept a rod or tool. In one embodiment, the handle 134 is inserted intothe aperture (not shown) and secured by tightening screw is 116 b inaperture 20 d. The rod manipulator 102 may be used in conjunction withexisting spinal screw and rod fixation systems. The size and thicknessof rods may be varied depending on the type of surgery, tensile strengthrequired and preference of the user.

FIG. 41 is a side view of a wide stance embodiment of the presentinvention that shows the rigid mechanical connection between theprovisional rods and the links. The space between malformed vertebraecan be quite narrow at times. A grip narrow enough to fit between themmay not be sufficiently stable under bending loads to be effective. Theadvantage of this double hook/screw grip is that the hooks can be narrowwhile still enabling a wide stable grip on the rods. In addition, twoset screws are better than one to prevent rotation on the small diameterrods. Again, it is possible to use fluted or faceted rods and acorresponding profile on the hooks to enhance rotational stability. FIG.41 is an image of a rod manipulator 104 positioned between pediclescrews 10 c and 10 d. Each of the pedicle screws 10 c and 10 d includesa bone fastener 12 c,d and a rod coupling head 14 c,d. The rod couplinghead 14 c,d includes a lower rod coupling 16 c,d having a lower rodopening 18 c,d, depicted in a lateral configuration. The lower rodopening 18 may have any angle so long as the material of the pediclescrew 10 c,d that surrounds the lower rod opening 18 c,d is sufficientlystrong to retain and affix a permanent rod. The lower rod coupling 16c,d also includes a bore 20 c,d, through which a permanent rod fastener22 c,d can be inserted to fasten a permanent rod 34 b. As in the case ofthe lower rod opening 18 c,d, the material of the pedicle screws 10 cand 10 d surrounding the bore 20 c,d will also be sufficiently strong toretain and affix a permanent rod 34 b. The rod manipulator 104 surroundspedicle screw 10 c. The rod manipulator 104 includes a head 130 having afirst jaw 200 and a second jaw 202 separated by jaw aperture 204. Thefirst jaw 200 includes a first rod coupling aperture 206 connected tothe temporary rod 34 b and screw 116 a inserted into the bore 20 d isused to engage and retain the temporary rod 34 b. The second jaw 202includes a second rod coupling aperture 208 connected to the temporaryrod 34 b and screw 116 b inserted into the bore 20 c is used to engageand retain the temporary rod 34 b.

FIG. 42 is a bottom side view of one embodiment of the rod manipulator102. The rod manipulator 102 provides a means to torque the links abouttheir axes, in addition to bending forces and axial pushing or pullingforces. In situations where the anatomy precludes placing the links atthe appropriate angle to correct the deformity, the prior art devicecannot be used to good advantage. By providing the links with a T-handlewhich enables twisting, the planar restriction of the device iseliminated. An intuitive combination of bending, twisting anddisplacement now enable true three dimensional spinal deformitycorrection. In this view screw is 116 are shown as well as first joint106. The rod manipulator 102 includes a head 130 that has an opening 132that first a rod 34 for spinal fixation. The screw 116 a is used toengage and retain the rod 34. The rod manipulator 102 includes a bodyportion 133 that includes the first joint 106. The first joint 106includes an aperture (not shown) to accept a rod or tool. In oneembodiment, the handle 134 is inserted into the aperture (not shown) andsecured by tightening screw is 116 b in aperture 20 d. The handleincludes a shaft 135 attached at one end to the first joint 106 and asecond bar or “T” bar 137. Although other shapes and configurations maybe used. The rod manipulator 102 may be used in conjunction withexisting spinal screw and rod fixation systems. The size and thicknessof rods may be varied depending on the type of surgery, tensile strengthrequired and preference of the user.

FIG. 43 is a side view of one embodiment of a rod clamp 400 of thepresent invention. The purpose of the connecting bar is to lock and holdthe links in a particular orientation once the correction has beenachieved but still permit free movement of the links during thecorrection procedure. The links are given round shafts so that theclamps can rotate on them. Existing rod to rod external fixation clampsare used to connect a rigid bar between the links. The result is aconnection which provides universal motion but can be securely lockedwhen the two rod-to-rod clamps are tightened. The rod clamp 400 has afirst side 402 and a second side 404 connected through a central point(not shown). The first side 402 has a first rod aperture 406 sized tofit a rod (not shown). The first side 402 has a first end 408 thatextends to a slot 410 and extends in a curve 412 to form first rodaperture 406 extending to second end 414 adjacent to first side 402separated by slot 410. The rod clamp 400 includes bolt (not shown) thatextends through the second end 414, the slot 410 and first end 408 beingcapped by nut 416. In operation, a rod (not shown) may be placed in thefirst rod aperture 406. The nut 416 is tightened, compressing the slot410 bringing second end 414 and the first end 408 closer together, andin turn reducing the size of the first rod aperture 406 to frictionallyfit the rod (not shown) in position. The second side 404 displays therod 418 inserted into second rod aperture 420 made from the curve 422.

FIG. 44 is a view of one embodiment of a rod clamp 500 of the presentinvention. The rod clamp 500 has a first side 502 and a second side 504connected through a connection junction 506. The first side 502 has afirst rod aperture 508 sized to fit a first rod 510. The first side 502has a first end 512 a that mates to second end 514 a separated by theslot junction 516 a. The first end 512 a has a first tab (not shown) andthe second end 514 a has a second tab (not shown) that form a first rodaperture 508 when the first end 512 a and the second end 514 a aremated. The second side 504 has a second rod aperture 516 sized to fit asecond rod 517. The first side 502 has a first end 512 b that mates tosecond end 514 b by slot junction 516 b. The first end 512 has a firsttab 518 and the second end 514 has a second tab 520 that form a secondrod aperture 516 when the first end 512 b and the second end 514 b aremated. The rod clamp 500 is secured by extending the bolt 522 throughthe first side 502, the connection junction 506 and the second side 504and securing with nut 524 and washer 526. The bolt 522 extends throughthe first end 512 a into the slot junction 516 a to mate to the secondend 514 a. The bolt 522 extends through the connection junction 506 intothe first end 512 b that mates to second end 514 b through slot junction516 b to secure the first side 502 relative to the second side 504. Inoperation, a first rod 510 is inserted into the first rod aperture 508of the first side 502 and a second rod 517 is inserted into the secondrod aperture 516 b of the second side 504. The nut 524 is tightenedcompressing the first side 502 to compress the first rod aperture 508and also compress the second side 504 and in turn the second rodaperture 516 and the connection junction 506. These clamps can be fullyencircling or partially encircling or a combination thereof. Partial orclamshell construction enables snapping the clamp onto a link at anypoint along the shaft. Full encirclement insures that the clamp will notaccidentally disengage from the link when in the loosened state. Ahybrid clamp composed of a partial half on one side and a fullyencircling one on the other would insure that the clamps stay retainedon one part while allowing that part to be easily attached to othercomponents. In addition, the connections between any of the first andsecond portions or the faces of mating of surfaces may be textured,faceted or splinned to enhance rotational stability.

FIG. 45 is a view of one embodiment of a rod clamp of the presentinvention in operation. The image illustrates the first rod manipulator102 a connected to the first rod clamp 500 a. The rod 510 extends fromthe first rod clamp 500 a to second rod clamp 500 b that is attached toa second rod manipulator 102 b. The first rod manipulator 102 a issecured to the artificial spine 600 through attachment to the temporaryrods 602 a and pedicle screws 604 a inserted into the artificial spine600. Similarly, the second rod manipulator 102 b is secured to theartificial spine 600 through attachment to the temporary rods 602 b andpedicle screws 604 b inserted into the artificial spine 600.

FIG. 46 is a view of some of the rods used with the present invention.The link contains a cross hole into which the provisional rod isinserted and then locked into place with a setscrew. The cross hole canbe configured to capture provisional rods of several differentdiameters. In addition, it can be configured to capture provisional rodsthat are faceted or splinned to enhance rotational stability.

FIG. 47 is a side view of one embodiment of the rod manipulator 102having an adjustable joint 470 in the handle 134 ending in a “T” handle137. The rod manipulator 102 provides a means to torque the links abouttheir axes, in addition to bending forces and axial pushing or pullingforces. In situations where the anatomy precludes placing the links atthe appropriate angle to correct the deformity, the prior art devicecannot be used to good advantage. By providing the links with a T-handlewhich enables twisting, the planar restriction of the device iseliminated. An intuitive combination of bending, twisting anddisplacement now enable true three dimensional spinal deformitycorrection. In this view screw is 116 are shown as well as first joint106. The rod manipulator 102 includes a head 130 that has an opening 132that first a rod 34 for spinal fixation. The screw 116 a is used toengage and retain the rod 34. The rod manipulator 102 includes a bodyportion 133 that includes the first joint 106. The first joint 106includes an aperture (not shown) to accept a rod or tool. In oneembodiment, the handle 134 is inserted into the aperture (not shown) andsecured by tightening screw is 116 b in aperture 20 d. The handleincludes a shaft 135 attached at one end to the first joint 106 and asecond bar or “T” bar 137. Furthermore, other shapes and configurationsmay be used. The rod manipulator 102 may be used in conjunction withexisting spinal screw and rod fixation systems. In this view, screw 116is shown, as well as first joint 106. This embodiment allows theattachment of a link that has already been secured to the spine. The rodmanipulator 102 includes a head 130 that has an opening 132 that first arod 34 for spinal fixation. The screw 116 a in aperture 20 c is used toengage and retain the rod 34. The rod manipulator 102 includes a bodyportion 133 that includes the first joint 106. The first joint 106includes an aperture (not shown) to accept a rod or tool. In oneembodiment, the handle 134 is inserted into the aperture (not shown) andsecured by tightening screw is 116 b in aperture 20 d. The rodmanipulator 102 may be used in conjunction with existing spinal screwand rod fixation systems. The adjustable joint 470 allows the relativeangle between the head 130 and the handle 134 ending in a “T” handle 137be adjusted as needed by rotating the adjustable joint 470 to thedesired position. The adjustable joint 470 may have a locking mechanismthat is depressed to allow adjustment and unlocking and released to lockin place. The size and thickness of rods may be varied depending on thetype of surgery, tensile strength required and preference of the user.

FIGS. 48A and 48B are images of the joint adapted into a joint of alarger device. FIG. 48A is an image of the first gear 200 positioned inthe head 264 of the first side 266 of the device aligned with the secondgear 226 positioned in the head 268 of the second half of the device270. The first gear 200 includes two or more teeth 204 and a centralaperture 258 that is aligned with the positioning cylinder 228 thatserves to align the two or more teeth 204 with the two or more secondteeth 248. FIG. 48B is an image of the first gear 200 positioned in thehead 264 of the first side 266 of the device mated to the second gear226 positioned in the head 268 of the second half of the device 270. Thefirst gear 200 includes two or more teeth 204 and a central aperture(not shown) that receives the positioning cylinder (not shown) thatserves to align the two or more teeth 204 with the two or more secondteeth 248.

FIG. 49 is an exploded isometric image of the joint adapted into alarger device. FIG. 49 is an exploded isometric left image that includesa joint 470 having a first body 472 that mates to a second body 474. Thefirst body 472 includes a first connection end 476 adjacent a first head278. The first head 478 includes a gear cavity 480 positioned within thefirst head 478 to receive a spring, spacer or washer 482 (optional) anda first gear 484 that is positioned between the body back portion 486and the front face 488. The first gear 484 includes a first gear back490 opposite a first gear face 492 that includes two or more first gearteeth 494 extending from the periphery of the first gear face 492 acrossthe face toward the center that are suitable to allow friction betweensurfaces. In the center of the first gear 484 is a first alignmentaperture 496 to aid in the alignment of the first gear 484. The secondbody 474 includes a second connection end 498 adjacent a second head501. The second head 500 includes a release recess 502 that extends fromthe outside inwardly into at least a portion of the second head 500.Within the release recess 502 there are numerous release apertures 504that extend from the release recess 502 through the second head 501. Arelease spring/washer 506 is positioned within the release recess 502. Arelease mechanism 508 is placed in contact with the spring/washer 506and the release pins 511 are passed through the numerous releaseapertures 504 and is secured by the retaining clip 512.

FIG. 50 is a view of one embodiment of a rod clamp of the presentinvention in operation. The image illustrates the first rod manipulator102 a connected to the first rod clamp 500 a. The rod 510 extends fromthe first rod clamp 500 a to second rod clamp 500 b that is attached toa second rod manipulator 102 b. The rod manipulator 102 a and 102 b havean adjustable joint 470 a and 470 b in shaft 135 a and 135 b attached atone end to a head 130 a and 130 b that has an opening 132 a and 132 bfor spinal fixation and a bar or “T” bar 137 a and 137 b at a secondend. The rod manipulators 102 a and 102 b provides a means to torque thelinks about their axes, in addition to bending forces and axial pushingor pulling forces. In situations where the anatomy precludes placing thelinks at the appropriate angle to correct the deformity, the prior artdevice cannot be used to good advantage. By providing the links with aT-handle which enables twisting, the planar restriction of the device iseliminated. An intuitive combination of bending, twisting anddisplacement now enable true three dimensional spinal deformitycorrection.

FIG. 51 is a view of another embodiment of a rod clamp of the presentinvention in operation. The image illustrates the first rod manipulator102 a connected to the first rod clamp 500 a. The rod 510 extends fromthe first rod clamp 500 a to second rod clamp 500 b that is attached toa second rod manipulator 102 b. The rod manipulator 102 a and 102 b havean adjustable joint 470 a and 470 b in shaft 135 a and 135 b attached atone end to a head 130 a and 130 b that has an opening 132 a and 132 bfor spinal fixation and a bar or “T” bar 137 a and 137 b at a secondend. The rod manipulators 102 a and 102 b provides a means to torque thelinks about their axes, in addition to bending forces and axial pushingor pulling forces. In situations where the anatomy precludes placing thelinks at the appropriate angle to correct the deformity, the prior artdevice cannot be used to good advantage. By providing the links with aT-handle which enables twisting, the planar restriction of the device iseliminated. An intuitive combination of bending, twisting anddisplacement now enable true three dimensional spinal deformitycorrection.

FIG. 52 shows an isometric view of one embodiment of the pedicle screwhaving a removable upper rod coupling. The pedicle screw 10 includes abone fastener 12 and a rod coupling head 14. The rod coupling head 14includes a lower rod coupling 16 having a lower rod opening 18. Thelower rod opening 18 may have any angle so long as the material of thepedicle screw 10 that surrounds the lower rod opening 18 is sufficientlystrong to retain and affix a permanent rod (not shown). The lower rodcoupling 16 also includes a bore 20, through which a permanent rodfastener 22 can be inserted to fasten a permanent rod (not shown). As inthe case of the lower rod opening 18, the material of the pedicle screw10 surrounding the bore 20 will also be sufficiently strong to retainand affix a permanent rod (not shown). The upper rod coupling 24 has anupper rod opening 26. The upper rod coupling 24 is formed to permit theuser to insert a temporary rod (not shown) using a temporary rodfastener 28. The lower coupling 16 and upper rod coupling 24 will oftenbe made of unitary construction. For illustration purposes, and notnecessarily as an element or limitation, a transition 32 is denoted. Inunitary embodiments, the transition 32 provides for the breakage betweenthe lower coupling 16 and the upper rod coupling 24 at breakpoint 38 forthe total separation of the lower coupling 16 and the upper rod coupling24. When made in a unitary construction, the pedicle screw 10 may bemachined, sintered, cast, welded or glued as long as the pedicle screwis of sufficient strength for the bone fixation application.

FIG. 53 shows a side view of one embodiment of the pedicle screw havinga removable upper rod coupling. The pedicle screw 10 includes a bonefastener 12 and a rod coupling head 14. The rod coupling head 14includes a lower rod coupling 16 having a lower rod opening 18. Thelower rod opening 18 may have any angle so long as the material of thepedicle screw 10 that surrounds the lower rod opening 18 is sufficientlystrong to retain and affix a permanent rod 36. The lower rod coupling 16also includes a bore 20, through which a permanent rod fastener 22 canbe inserted to fasten a permanent rod 36. As in the case of the lowerrod opening 18, the material of the pedicle screw 10 surrounding thebore 20 will also be sufficiently strong to retain and affix a permanentrod 36. The upper rod coupling 24 has an upper rod opening 26. The upperrod coupling 24 is formed to permit the user to insert a temporary rod34 using a temporary rod fastener 28. The lower coupling 16 and upperrod coupling 24 will often be made of unitary construction. Forillustration purposes, and not necessarily as an element or limitation,a transition 32 is denoted. In unitary embodiments, the transition 32provides for the breakage between the lower coupling 16 and the upperrod coupling 24 at breakpoint 38 for the total separation of the lowercoupling 16 and the upper rod coupling 24. When made in a unitaryconstruction, the pedicle screw 10 may be machined, sintered, cast,welded or glued as long as the pedicle screw is of sufficient strengthfor the bone fixation application.

FIG. 54 shows a front view of one embodiment of the pedicle screw havinga removable upper rod coupling. The pedicle screw 10 includes a bonefastener 12 and a rod coupling head 14. The rod coupling head 14includes a lower rod coupling 16 having a lower rod opening 18. Thelower rod opening 18 may have any angle so long as the material of thepedicle screw 10 that surrounds the lower rod opening 18 is sufficientlystrong to retain and affix a permanent rod (not shown). The lower rodcoupling 16 also includes a bore 20, through which a permanent rodfastener 22 can be inserted to fasten a permanent rod (not shown). As inthe case of the lower rod opening 18, the material of the pedicle screw10 surrounding the bore 20 will also be sufficiently strong to retainand affix a permanent rod (not shown). The upper rod coupling 24 has anupper rod opening (not shown). The upper rod coupling 24 is formed topermit the user to insert a temporary rod (not shown) using a temporaryrod fastener 28. The lower coupling 16 and upper rod coupling 24 willoften be made of unitary construction. For illustration purposes, andnot necessarily as an element or limitation, a transition 32 is denoted.In unitary embodiments, the transition 32 provides for the breakagebetween the lower coupling 16 and the upper rod coupling 24 atbreakpoint 38 for the total separation of the lower coupling 16 and theupper rod coupling 24. When made in a unitary construction, the pediclescrew 10 may be machined, sintered, cast, welded or glued as long as thepedicle screw is of sufficient strength for the bone fixationapplication.

FIG. 55 shows an isometric view of one embodiment of the pedicle screwhaving a removable upper rod coupling showing the permanent rod andtemporary rod. The pedicle screw 10 includes a bone fastener 12 and arod coupling head 14. The rod coupling head 14 includes a lower rodcoupling 16 having a lower rod opening 18. The lower rod opening 18 mayhave any angle so long as the material of the pedicle screw 10 thatsurrounds the lower rod opening 18 is sufficiently strong to retain andaffix a permanent rod 36. The lower rod coupling 16 also includes a bore20, through which a permanent rod fastener 22 can be inserted to fastena permanent rod 36. As in the case of the lower rod opening 18, thematerial of the pedicle screw 10 surrounding the bore 20 will also besufficiently strong to retain and affix a permanent rod 36. The upperrod coupling 24 has an upper rod opening 26. The upper rod coupling 24is formed to permit the user to insert a temporary rod 34 using atemporary rod fastener 28. The lower coupling 16 and upper rod coupling24 will often be made of unitary construction. For illustrationpurposes, and not necessarily as an element or limitation, a transition32 is denoted. In unitary embodiments, the transition 32 provides forthe breakage between the lower coupling 16 and the upper rod coupling 24at breakpoint 38 for the total separation of the lower coupling 16 andthe upper rod coupling 24. When made in a unitary construction, thepedicle screw 10 may be machined, sintered, cast, welded or glued aslong as the pedicle screw is of sufficient strength for the bonefixation application.

FIG. 56 shows an isometric view of one embodiment of the pedicle screwhaving a removable upper rod coupling showing temporary rod with theupper rod coupling removal tool. The pedicle screw 10 includes a bonefastener 12 and a rod coupling head 14. The rod coupling head 14includes a lower rod coupling 16 having a lower rod opening 18. Thelower rod opening 18 may have any angle so long as the material of thepedicle screw 10 that surrounds the lower rod opening 18 is sufficientlystrong to retain and affix a permanent rod 36. The lower rod coupling 16also includes a bore 20, through which a permanent rod fastener 22 canbe inserted to fasten a permanent rod 36. As in the case of the lowerrod opening 18, the material of the pedicle screw 10 surrounding thebore 20 will also be sufficiently strong to retain and affix a permanentrod 36. The upper rod coupling 24 has an upper rod opening 26. The upperrod coupling 24 is formed to permit the user to insert a temporary rod(not shown) using a temporary rod fastener (not shown). The lowercoupling 16 and upper rod coupling 24 will often be made of unitaryconstruction. For illustration purposes, and not necessarily as anelement or limitation, a transition 32 is denoted. In unitaryembodiments, the transition 32 provides for the breakage between thelower coupling 16 and the upper rod coupling 24 at breakpoint 38 for thetotal separation of the lower coupling 16 and the upper rod coupling 24.The upper rod coupling removal tool 15 is used by positioning it aboutthe upper rod coupling 24 to break at the transition 32 and atbreakpoint 38 between the lower coupling 16 and the upper rod coupling24. When made in a unitary construction, the pedicle screw 10 may bemachined, sintered, cast, welded or glued as long as the pedicle screwis of sufficient strength for the bone fixation application.

FIG. 57 shows an isometric view of one embodiment of the pedicle screwhaving a removable upper rod coupling showing temporary rod with theupper rod coupling removal tool. The pedicle screw 10 includes a bonefastener 12 and a rod coupling head 14. The rod coupling head 14includes a lower rod coupling 16 having a lower rod opening 18. Thelower rod opening 18 may have any angle so long as the material of thepedicle screw 10 that surrounds the lower rod opening 18 is sufficientlystrong to retain and affix a permanent rod 36. The lower rod coupling 16also includes a bore 20, through which a permanent rod fastener 22 canbe inserted to fasten a permanent rod 36. As in the case of the lowerrod opening 18, the material of the pedicle screw 10 surrounding thebore 20 will also be sufficiently strong to retain and affix a permanentrod 36. The upper rod coupling 24 has an upper rod opening 26. The upperrod coupling 24 is formed to permit the user to insert a temporary rod(not shown) using a temporary rod fastener (not shown). The lowercoupling 16 and upper rod coupling 24 will often be made of unitaryconstruction. For illustration purposes, and not necessarily as anelement or limitation, a transition 32 is denoted. In unitaryembodiments, the transition 32 provides for the breakage between thelower coupling 16 and the upper rod coupling 24 at breakpoint 38 for thetotal separation of the lower coupling 16 and the upper rod coupling 24.The upper rod coupling removal tool 15 is used by positioning it aboutthe upper rod coupling 24 to break 39 at the transition 32 and atbreakpoint 38 between the lower coupling 16 and the upper rod coupling24. When made in a unitary construction, the pedicle screw 10 may bemachined, sintered, cast, welded or glued as long as the pedicle screwis of sufficient strength for the bone fixation application.

FIG. 58 shows an isometric view of one embodiment of the pedicle screwshowing the permanent rod with the upper rod coupling removed. Thepedicle screw 10 includes a bone fastener 12 and a rod coupling head 14(not shown). The rod coupling head 14 (not shown) includes a lower rodcoupling 16 having a lower rod opening 18. The lower rod opening 18 mayhave any angle so long as the material of the pedicle screw 10 thatsurrounds the lower rod opening 18 is sufficiently strong to retain andaffix a permanent rod 36. The lower rod coupling 16 also includes a bore20, through which a permanent rod fastener 22 can be inserted to fastena permanent rod 36. As in the case of the lower rod opening 18, thematerial of the pedicle screw 10 surrounding the bore 20 will also besufficiently strong to retain and affix a permanent rod 36. The upperrod coupling (not shown) has been removed. The transition 32 providesfor the breakage between the lower coupling 16 and the upper rodcoupling (not shown) for the total separation of the lower coupling 16and the upper rod coupling (not shown). When made in a unitaryconstruction, the pedicle screw 10 may be machined, sintered, cast,welded or glued as long as the pedicle screw is of sufficient strengthfor the bone fixation application.

FIG. 59 shows an isometric view of one embodiment of the pedicle screwwith the upper rod coupling removed. The pedicle screw 10 includes abone fastener 12 and a rod coupling head 14 (not shown). The rodcoupling head 14 (not shown) includes a lower rod coupling 16 having alower rod opening 18. The lower rod opening 18 may have any angle solong as the material of the pedicle screw 10 that surrounds the lowerrod opening 18 is sufficiently strong to retain and affix a permanentrod 36 (not shown). The lower rod coupling 16 also includes a bore 20,through which a permanent rod fastener (not shown) can be inserted tofasten a permanent rod (not shown). As in the case of the lower rodopening 18, the material of the pedicle screw 10 surrounding the bore 20will also be sufficiently strong to retain and affix a permanent rod(not shown). The upper rod coupling (not shown) has been removed. Thetransition 32 provides for the breakage between the lower coupling 16and the upper rod coupling (not shown) for the total separation of thelower coupling 16 and the upper rod coupling (not shown). When made in aunitary construction, the pedicle screw 10 may be machined, sintered,cast, welded or glued as long as the pedicle screw is of sufficientstrength for the bone fixation application.

The rod manipulators may be used in conjunction with existing spinalscrew and rod fixation systems or may be used in conjunction with thepedicle screw. The size and thickness of rods may be varied depending onthe type of surgery, tensile strength required and preference of theuser.

The new rod link frame is strong enough and rigid enough that, in manycases, it can be used alone on one side of the spine to achieve and holda correction while a permanent rod is inserted on the other side. Thismeans that standard pedicle screws, configured to hold a single rod canbe used and the device is adaptable to a broad range of spinal implantsystems.

It is contemplated that any embodiment discussed in this specificationcan be implemented with respect to any method, kit, reagent, orcomposition of the invention, and vice versa. Furthermore, compositionsof the invention can be used to achieve methods of the invention.

It will be understood that particular embodiments described herein areshown by way of illustration and not as limitations of the invention.The principal features of this invention can be employed in variousembodiments without departing from the scope of the invention. Thoseskilled in the art will recognize, or be able to ascertain using no morethan routine experimentation, numerous equivalents to the specificprocedures described herein. Such equivalents are considered to bewithin the scope of this invention and are covered by the claims.

All publications and patent applications mentioned in the specificationare indicative of the level of skill of those skilled in the art towhich this invention pertains. All publications and patent applicationsare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

The use of the word “a” or “an” when used in conjunction with the term“comprising” in the claims and/or the specification may mean “one,” butit is also consistent with the meaning of “one or more,” “at least one,”and “one or more than one.” The use of the term “or” in the claims isused to mean “and/or” unless explicitly indicated to refer toalternatives only or the alternatives are mutually exclusive, althoughthe disclosure supports a definition that refers to only alternativesand “and/or.” Throughout this application, the term “about” is used toindicate that a value includes the inherent variation of error for thedevice, the method being employed to determine the value, or thevariation that exists among the study subjects.

As used in this specification and claim(s), the words “comprising” (andany form of comprising, such as “comprise” and “comprises”), “having”(and any form of having, such as “have” and “has”), “including” (and anyform of including, such as “includes” and “include”) or “containing”(and any form of containing, such as “contains” and “contain”) areinclusive or open-ended and do not exclude additional, unrecitedelements or method steps.

The term “or combinations thereof” as used herein refers to allpermutations and combinations of the listed items preceding the term.For example, “A, B, C, or combinations thereof” is intended to includeat least one of: A, B, C, AB, AC, BC, or ABC, and if order is importantin a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB.Continuing with this example, expressly included are combinations thatcontain repeats of one or more item or term, such as BB, AAA, MB, BBC,AAABCCCC, CBBAAA, CABABB, and so forth. The skilled artisan willunderstand that typically there is no limit on the number of items orterms in any combination, unless otherwise apparent from the context.

All of the compositions and/or methods disclosed and claimed herein canbe made and executed without undue experimentation in light of thepresent disclosure. While the compositions and methods of this inventionhave been described in terms of preferred embodiments, it will beapparent to those of skill in the art that variations may be applied tothe compositions and/or methods and in the steps or in the sequence ofsteps of the method described herein without departing from the concept,spirit and scope of the invention. All such similar substitutes andmodifications apparent to those skilled in the art are deemed to bewithin the spirit, scope and concept of the invention as defined by theappended claims.

REFERENCES

-   1. Maclennan A. Scoliosis. Br Med J 1922; 2: 865-6.-   2. Compere E L. Excision of hemivertebrae for correction of    congenital scoliois: report of two cases. JBJS 1932; 14-A; 555-62.-   3. Deviten V, Berven S, Smith JA, et al. Excision of hemivertebrae    in the management of congenital scoliosis involving the thoracic and    thoracolumbar spine. JBJS 2001; 83-B; 496-500.-   4. Floman Y, Penny J N, Micheli L J, et al. Osteotomy of the fusion    mass in scoliosis. JBJS 1982; 64-A: 1307-16.-   5. Luque E R. Vertebral column transposition. Orthop Trans 1983; 7:    29.-   6. Leatherman k D, Dickson R A. Two-stage corrective surgery for    congenital deformities of the spine. JBJS 1979; 61-B: 324-8.-   7. Tokunaga M, Minami S, Kitahara H, et al. Verteral decancellation    for severe scoliosis. Spine 2000; 25: 469-74.-   8. Wiles P. Resection of dorsalvertebrae in congenital scoliosis.    JBJS 1951, 33-A: 151-4.-   9. Bradford D S. Vertebral column resection. Orthop Tans 1987; 11:    502.-   10. Bradford D S and Boachie-Adjei O. One-stage anterior and    posterior hemivertebral resection and arthrodesis for congenital    scoliosis. JBJS 1990; 72-A: 536-40.-   11. Suk S, Kim J H, Kim W J, et al. Posterior vertebral column    resection for severe spinal deformities. Spine 2002; 27 (21):    2374-82.-   12. Suk S, Chung E R, Kim J H, et al. Posterior vertebral column    resection for severe spinal deformities. Spine 2005; 30 (14):    1682-87.-   13. Suk S, Chung E R, Lee S M, et al. Posterior vertebral column    resection in fixed lumbosacral deformity. Spine 2005; 30 (23):    E703-10.

What is claimed is:
 1. A pedicle screw for spinal fixation comprising: abone fastener portion, wherein the bone fastener portion is at leastpartially threaded; a permanent rod coupling comprising a bottom surfaceconnected to the bone fastener portion, a middle section positionedbetween the bottom surface and a top surface, a lateral rod opening in aportion of the middle section adapted to receive a permanent rod, athreaded bore that extends from the top surface into the lateral rodopening, a permanent rod fastener mated to fit the threaded bore toextend into the lateral rod opening, wherein the permanent rod fastenercan engage a permanent rod positioned in the lateral rod opening, and atransition region on a portion of the top surface; a breakaway portionin the transition region; a temporary rod coupling connected to thetransition region, wherein the temporary rod coupling comprises atemporary rod channel adapted to receive a temporary rod, an upperthreaded opening that extends into the temporary rod channel, and anupper rod fastener mated to the upper threaded opening, wherein theupper rod fastener can engage the temporary rod positioned in thetemporary rod channel; wherein the permanent rod is positioned in thelateral rod opening and secured by the permanent rod fastener during thebone alignment and the temporary rod is temporarily positioned in thetemporary rod channel and secured by the upper rod fastener during abone realignment and when the temporary rod is not needed the temporaryrod coupling can be removed at the transition region by separation atthe breakaway portion to leave the top surface.
 2. The screw of claim 1,wherein the permanent rod fastener, the upper rod fastener or both arethreaded.
 3. The screw of claim 1, wherein the lateral rod opening andthe temporary rod channel are generally perpendicular.
 4. The screw ofclaim 1, wherein the temporary rod channel and the bone fastener portionare generally parallel.
 5. The screw of claim 1, wherein the lateral rodopening and the bone fastener portion are generally perpendicular. 6.The screw of claim 1, wherein the permanent rod fastener, the upper rodfastener or both further comprise a locking pin to prevent movement. 7.The screw of claim 1, wherein the bone fastener is permanently attachedto the permanent rod coupling.
 8. The screw of claim 1, wherein the bonefastener is semi-permanently attached to the permanent rod coupling toallow the permanent rod coupling to be positioned at a variable anglerelative to the bone fastener.
 9. A method of spinal fixation usingpedicle screws comprising the steps of: fastening two or more pediclescrews into two or more vertebra, wherein the each of the two or morepedicle screws comprise a bone fastener portion; a permanent rodcoupling comprising a bottom surface connected to the bone fastenerportion, a middle section positioned between the bottom surface and atop surface, a lateral rod opening in a portion of the middle sectionadapted to receive a permanent rod, a threaded bore that extends fromthe top surface into the lateral rod opening, a permanent rod fastenermated to fit the threaded bore to extend into the lateral rod opening,wherein the permanent rod fastener can engage a permanent rod positionedin the lateral rod opening, and a transition region on a portion of thetop surface; a breakaway portion in the transition region; a temporaryrod coupling connected to the transition region, wherein the temporaryrod coupling comprises a temporary rod channel adapted to receive atemporary rod, an upper threaded opening that extends into the temporaryrod channel, and an upper rod fastener mated to the upper threadedopening, wherein the upper rod fastener can engage the temporary rodpositioned in the temporary rod channel; and interconnecting the two ormore pedicle screws by securing the permanent rod in the lateral rodopening of at least two of the two or more pedicle screws, securing thetemporary rod in the temporary rod channel of at least two of the two ormore pedicle screws, or both.
 10. The method of claim 9, furthercomprising the step of removing the temporary rod from the temporary rodchannel.
 11. The method of claim 9, further comprising the step ofbreaking the temporary rod coupling at the breakaway portion of thetransition region to leave the top surface.
 12. The method of claim 9,wherein the permanent rod fastener, the upper rod fastener or boththreadably engage the temporary, permanent or both rods.
 13. The methodof claim 9, wherein the lateral rod opening and the temporary rodchannel are generally perpendicular.
 14. The method of claim 9, whereinthe temporary rod channel and the bone fastener portion are generallyparallel.
 15. The method of claim 9, wherein the lateral rod opening andthe bone fastener portion are generally perpendicular.
 16. The method ofclaim 9, wherein the permanent rod fastener, the upper rod fastener orboth further comprise a locking pin to prevent movement.
 17. The methodof claim 9, wherein the bone fastener is permanently attached to thepermanent rod coupling.
 18. The method of claim 9, wherein the bonefastener is semi-permanently attached to the permanent rod coupling toallow the permanent rod coupling to be positioned at a variable anglerelative to the bone fastener.
 19. A pedicle screw kit for spinalfixation comprising: two or more pedicle screws, wherein each of the twoor more pedicle screws comprise a bone fastener portion, wherein thebone fastener portion is at least partially threaded; a permanent rodcoupling comprising a bottom surface connected to the bone fastenerportion, a middle section positioned between the bottom surface and atop surface, a lateral rod opening in a portion of the middle sectionadapted to receive a permanent rod, a threaded bore that extends fromthe top surface into the lateral rod opening, a permanent rod fastenermated to fit the threaded bore to extend into the lateral rod opening,wherein the permanent rod fastener can engage a permanent rod positionedin the lateral rod opening, and a transition region on a portion of thetop surface; a breakaway portion in the transition region; a temporaryrod coupling connected to the transition region, wherein the temporaryrod coupling comprises a temporary rod channel adapted to receive atemporary rod, an upper threaded opening that extends into the temporaryrod channel, and an upper rod fastener mated to the upper threadedopening, wherein the upper rod fastener can engage the temporary rodpositioned in the temporary rod channel; wherein the permanent rod ispositioned in the lateral rod opening and secured by the permanent rodfastener during the bone alignment and the temporary rod is temporarilypositioned in the temporary rod channel and secured by the upper rodfastener during a bone realignment and when the temporary rod is notneeded the temporary rod coupling can be removed at the transitionregion by separation at the breakaway portion to leave the top surface.20. The kit of claim 19, further comprising a breakaway tool adapted tofit the temporary rod coupling to break off the temporary rod coupling.21. The kit of claim 19, further comprising one or more rod linkreducers, at least one permanent rod, at least one temporary rod, one ormore leverage handles or a combination thereof.